BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT Ø1.8 L125 2FLUTE

    MDR report key: 2878701 · Received December 18, 2012

    Report

    Report Number
    2520274-2012-04114
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    July 7, 2009
    Manufacturer
    SYNTHES
    Product Code
    HSZ
    PMA / PMN Number
    NON-US
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HTW. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE EU COMPLAINT HANDLING UNIT REPORTED THAT THE TWO OF FOUR DRILL BITS BROKE AT THE HOSPITAL. TWO BROKE INSIDE THE PATIENT'S BODY AND THE PIECES REMAIN IN PATIENT. THE HOSPITAL USE THESE DRILL BITS FREQUENTLY AND FEEL THEY ARE FAULTY DUE TO THE NUMBER OF BREAKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT Ø1.8 L125 2FLUTE MANDIBLE DRILL BITS HSZ SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention